SPOTLIGHT 292908011Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034225906), received between Jan 8, 2020 and Jan 8, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2020Break; Break

  THE TIP OF THE VIPER FINAL TIGHTENER DRIVER #286745550 GOT STRIPPED DURING THE FINAL TIGHTENING PROCESS. THE TIP OF THE SUCTION #292908011 IS DAMAGED. IT SEEMS THAT IT GOT WORN OUT DUE TO REPEATED USE ALONG SIDE CUTTING INSTRUMENTS. NO-CHARGE REPLACEMENTS NEEDED FOR BOTH. PO#2697726. CUSTOMER REFERENCE/PO/SERVICE: (B)(4), WAS SURGERY DELAYED DUE TO THE REPORTED EVENT?: UNKNOWN, WAS PROCEDURE SUCCESSFULLY COMPLETED?: UNKNOWN, WERE FRAGMENTS GENERATED?: UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION?: UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9564915 ↗